FDA New Policy on Emergency Use Authorization (EUA) of In Vitro Diagnostics of Coronavirus
On February 2020, FDA issued a Policy that allows CLIA certified high-complexity testing laboratories to use their validated diagnostic tests to detect the SARS-CoV-2 virus in specimen while they are preparing for EUA submission to FDA.
NMPA Emergency Approval of Imported Medical Devices in China: What this means for Foreign Manufacturers
The Coronavirus outbreak in China has led to an extraordinary demand of some medical devices. The NMPA (Chinese health authority) started granting emergency approval to some imported medical device, provided that they meet certain regulatory and quality standards.